The UK’s healthcare regulator has suspended marketing approval for a widely used antibiotic that had won clearance based on clinical trials conducted by India’s Quest Life Sciences, due to concerns over the integrity of trial data.
The Medicines and Healthcare products Regulatory Agency (MHRA) might also deny other pending drug approval requests that rely on studies conducted by Quest, the UK agency said in a letter dated June 22, a copy of which was seen by Reuters.
The MHRA’s decision bars the sale of a generic version of erythromycin that is being sold in the UK by Dawa Ltd, a Kenyan drugmaker, an MHRA spokesman said.
According to report, the company plans to appeal against the MHRA suspension as he believes the agency relied on a two-year-old study and the following inspection report to reach its decision, and that it did not review the company’s latest quality management systems.
He said Quest had significantly improved its quality systems since 2014, and would ask the MHRA to re-inspect its site, as MHRA’s move means four other drugs Quest performed trials on that are awaiting approval with the UK regulator will not be approved until the agency clears its facility.
These drugs include the antibiotics doxycycline and cephalexin, and the diabetes drug metformin, on which Quest had conducted trials on behalf of UK drugmaker Strandhaven and India’s Kopran.
Strandhaven, Kopran and Dawa did not respond to requests for comment on the matter.
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